University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
NCT Number: NCT02433496
This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.
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Notify Me18 year and older
All sexes
Observational
Madison, Wisconsin, 53705, United States
This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.
The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.
Exclusion criteria
The coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.
The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice.
Time frame: Up to 3 years
The proportion of patients with a chronic pain diagnosis receiving daily opioids.
Time frame: Up to 3 years
Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
Time frame: Up to 3 years
Proportion of opioid patients completing urine drug screens prior to and during the study intervention
Time frame: Up to 3 years
Proportion of opioid patients screened for mental health/substance use problems
Time frame: Up to 3 years
Proportion of opioid patients signing pain management agreements
Time frame: Up to 3 years
Proportion of opioid prescriptions above 120 mg daily morphine equivalent
Time frame: 3 months
Number and percentage of providers who drop out of study at 3 months
Time frame: Up to 3 years
Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
Time frame: Up to 12 months
Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
Time frame: Up to 12 months
Characteristics of participating staff (profession)
Time frame: Up to 12 months
Total hours of coaching delivered/received among all clinics that received physician coaching.
Time frame: Up to 12 months
Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.
Time frame: Up to 12 months
The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
Time frame: Up to 12 months
The average MEDD in milligrams for patients with consistent opioid Rx.
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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